Sr Principal Statistician
Jazz Pharmaceuticals
6 months ago
Remote friendly (Palo Alto, CA)
United States
Clinical Research and Development
Brief Description
- Lead statistical work on individual studies, related studies, and integrated summaries; design and report Phase I–IV clinical studies and regulatory filings under supervision of a more senior statistician.
- Own statistical aspects of study design, study analysis and validation, and study documentation.
- Provide timely, scientifically sound statistical expertise to clinical development projects; develop and execute statistical strategy, design, and analyses for clinical trials.
- Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
- Manage work completed by external statistics and programming vendors.
Essential Functions
- Optimize clinical study designs, endpoints, and analysis strategies in protocols through department and cross-functional meetings.
- Collaborate cross-functionally to meet report timelines.
- Support development and implementation of study protocols.
- Review/provide input to data capture systems and participate in their validation.
- Develop statistical programs to simulate trial operating characteristics, perform analyses, prepare data displays, and verify accuracy/validity of programming outputs.
- Write and review Statistical Analysis Plans (SAPs); oversee analysis, validation, and interpretation.
- Prepare for and attend regulatory agency meetings.
- Help develop, implement, and maintain biostatistics department standards and practices.
- Review CRO timelines and analysis plans to ensure timeliness and quality.
- Review and validate CRO deliverables.
- Serve as statistical SME for clinical reports, integrated summaries, and other documents.
- Respond to statistical questions from regulatory agencies.
Required Knowledge, Skills, and Abilities
- Clinical trial design and analysis knowledge, including complex methods/models, statistical inference, hypothesis testing, estimates, parametric/non-parametric models, sample size calculations, design of experiments, and Phase II–IV data analysis.
- SAS and R experience (other statistical tools/programming languages a plus).
- Knowledge of regulatory requirements/guidelines (e.g., ICH) and statistical contributions to marketing applications; CDISC standards.
- Ability to work in a fast-paced, flexible, team-oriented environment.
- Strong written/verbal communication and interpersonal skills; excellent attention to detail.
- Flexible, positive, creative thinker; able to work without close supervision and manage time effectively.
Required/Preferred Education and Licenses
- MS or MPH in statistics, mathematics, or related discipline with statistical focus, and >4 years pharma/biotech experience.
- PhD in statistics, mathematics, or related discipline with statistical focus, and >2 years pharma/biotech experience.
- Knowledge of drug development regulations pertinent to statistical analysis.
- Preferred: oncology/hematology therapeutic area knowledge.
- Preferred: Bayesian and adaptive design experience.
- Proficient SAS & R programming; solid CDISC models/standards understanding.
- Excellent writing/communication; demonstrated leadership and interpersonal skills.
Benefits (if US-based)
- Eligible for medical, dental, and vision insurance; 401k retirement plan; flexible paid vacation.
- Base pay range (US-based candidates only): $156,000.00–$234,000.00.
Application Instructions
- If you are a current Jazz employee, apply via the Internal Career site.
- Lead statistical work on individual studies, related studies, and integrated summaries; design and report Phase I–IV clinical studies and regulatory filings under supervision of a more senior statistician.
- Own statistical aspects of study design, study analysis and validation, and study documentation.
- Provide timely, scientifically sound statistical expertise to clinical development projects; develop and execute statistical strategy, design, and analyses for clinical trials.
- Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
- Manage work completed by external statistics and programming vendors.
Essential Functions
- Optimize clinical study designs, endpoints, and analysis strategies in protocols through department and cross-functional meetings.
- Collaborate cross-functionally to meet report timelines.
- Support development and implementation of study protocols.
- Review/provide input to data capture systems and participate in their validation.
- Develop statistical programs to simulate trial operating characteristics, perform analyses, prepare data displays, and verify accuracy/validity of programming outputs.
- Write and review Statistical Analysis Plans (SAPs); oversee analysis, validation, and interpretation.
- Prepare for and attend regulatory agency meetings.
- Help develop, implement, and maintain biostatistics department standards and practices.
- Review CRO timelines and analysis plans to ensure timeliness and quality.
- Review and validate CRO deliverables.
- Serve as statistical SME for clinical reports, integrated summaries, and other documents.
- Respond to statistical questions from regulatory agencies.
Required Knowledge, Skills, and Abilities
- Clinical trial design and analysis knowledge, including complex methods/models, statistical inference, hypothesis testing, estimates, parametric/non-parametric models, sample size calculations, design of experiments, and Phase II–IV data analysis.
- SAS and R experience (other statistical tools/programming languages a plus).
- Knowledge of regulatory requirements/guidelines (e.g., ICH) and statistical contributions to marketing applications; CDISC standards.
- Ability to work in a fast-paced, flexible, team-oriented environment.
- Strong written/verbal communication and interpersonal skills; excellent attention to detail.
- Flexible, positive, creative thinker; able to work without close supervision and manage time effectively.
Required/Preferred Education and Licenses
- MS or MPH in statistics, mathematics, or related discipline with statistical focus, and >4 years pharma/biotech experience.
- PhD in statistics, mathematics, or related discipline with statistical focus, and >2 years pharma/biotech experience.
- Knowledge of drug development regulations pertinent to statistical analysis.
- Preferred: oncology/hematology therapeutic area knowledge.
- Preferred: Bayesian and adaptive design experience.
- Proficient SAS & R programming; solid CDISC models/standards understanding.
- Excellent writing/communication; demonstrated leadership and interpersonal skills.
Benefits (if US-based)
- Eligible for medical, dental, and vision insurance; 401k retirement plan; flexible paid vacation.
- Base pay range (US-based candidates only): $156,000.00–$234,000.00.
Application Instructions
- If you are a current Jazz employee, apply via the Internal Career site.